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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02287857
Other study ID # CTTQ-TDF-V4.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date October 2019

Study information

Verified date March 2019
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Yan yan Yu, doctor
Phone 13901194223
Email yyy@bjnu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B

- Aged 18 to 65 years old,male or female

- Patients with previously HBsAg-positive lasted for 6months at least:HBeAg-positive subjects, HBV-DNA> 105copies/ml; HBeAg-negative subjects, HBV-DNA> 104copies/ml.

- 2 times the upper normal limit (2 × ULN) = alanine aminotransferase (ALT) = 10 × ULN.

- Total serum bilirubin (TBIL) = 2.5 × ULN.

- Prothrombin activity (PTA) = 60% or prothrombin time prolonged than normal = 3 seconds).

- WBC = 3.5 × 109 / L, PLT = 80 × 109 / L, serum albumin (ALB)= 35 g / L.

- Creatinine (Cr) = 1× ULN,serum phosphate was normal.

- Patients signed an informed consent form and compliance was good.

Exclusion Criteria:

- Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.

- Patients with cirrhosis or liver cancer.

- Pregnant woman, lactating women .

- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.

- Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.

- Patients allergic for study drug.

Study Design


Intervention

Drug:
Domestic Tenofovir Disoproxil Fumarate Tablets
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Tenofovir Disoproxil Fumarate Tablets of Gilead
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead

Locations

Country Name City State
China Beijing Ditan Hospital Capital Medical University Beijing Beijing
China Beijing You An Hospital, Capital Medical University Beijing Beijing
China Peking University First Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China West China Hospital of Sichuan University Chengdou Sichuan
China First Affiliated Hospital, Third Military Medical University Chongqing Chongqing
China Third Affiliated Hospital of Sun Yat-sen Guangzhou Guangdong
China First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The Second Hospital of Nanjing Nanjing Jiangsu
China Huashan Hospital, Fudan University Shanghai Shanghai
China Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Shanghai Public Health Clinical Center Shanghai Shanghai
China First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compared with baseline, decline of serum HBV-DNA in the value 48 week
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